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    Tool · 510(k)

    510(k) Predicate Finder

    Find potential predicate devices for your 510(k) submission. Enter a K-number to find all clearances with the same product code, a three-letter product code to browse clearances directly, or search by device name.

    Product Code: DXJ FDA class 2

    Display, Cathode-Ray Tube, Medical

    Cardiovascular

    View full classification →

    The Medical Cathode-Ray Tube Display is a cardiovascular electronic display device used to visually present physiological waveforms, numerical data, or diagnostic images from monitoring or imaging equipment at the point of care or on a medical workstation. It is classified as an FDA Class 2 device, indicating moderate risk, and requires 510(k) premarket notification before marketing. The product code is DXJ and it is regulated under 21 CFR 870.2450 within the Cardiovascular medical specialty. This device is eligible for third-party 510(k) review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    ESSENZ Patient Monitor
    Philips IntelliVue GuardianSoftware (Rev. E.0X)
    Essence 55SP Large Monitor System
    Vios Central Station Monitor Software, Vios Central Server Software
    Philips IntelliVue GuardianSoftware
    Nexxis OR
    Essence 55S Large Monitor System
    Sorin Connect
    Nexxis OR, Nexxis
    NIVR58-T kit
    Philips IntelliVue GuardianSoftware
    CARESCAPE Central Station V2
    Philips CS770 IntelliSpace Critical Care and Anesthesia
    Philips IntelliVue GuardianSoftware
    SIVR56-T KIT
    CARESCAPE CENTRAL STATION (FORMALLY KNOWN AS CIC PRO)
    ZOLL CODE WRITER
    SIREN EPCR SUITE
    ZOLL EPCR IOS
    SORIN CONNECT DATA MANAGEMENT SYSTEM
    NEXXIS OR
    TLINK DATA MANAGEMENT SYSTEM (DMS)
    INTELLIVUE GUARDIAN SOFTWARE MODEL 866009, INTELLIVUE CL SP02 POD MODEL 865215, INTELLIVUE CL NBP POD MODEL 865216
    RADIFORCE LARGE MONITOR SYSTEM
    ZOLL RESCUENET EPCR MODEL RESCUENET EPCR
    VANTAGE VIEW SYSTEM
    MD VISION SYSTEM
    INTELLIVUE CLINICAL INFORMATION PORTFOLIO
    CARDIO-VIEW
    ELECTROPHYSIOLOGY SYSTEMS INTEGRATOR (EPSI)
    MODIFICATION TO: CIC PRO CLINICAL INFORMATION CENTER CENTRAL STATION
    INFINITY EXPLORER
    GE MARQUETTE CLINICAL INFORMATION CENTER, GE MARQUETTE CIC
    HP CAREVUE 9000 CLINICAL INFORMATION SYSTEM, MODEL M2331A
    ECG REVIEW STATION
    SPACELABS MEDICAL MULTI-DISCLOSURE WORKSTATION
    HEWLETT-PACKARD MODEL M1490A WIRELESS PATIENT DATA COMMUNICATOR
    580CDR DISPLAY DRIVER
    620CSR DISPLAY DRIVER
    516YT DISPLAY DRIVER
    580CD DISPLAY DRIVER
    SPACELABS MEDICAL INTEGRATED CLINICAL DISPLAY
    MODEL M1251A MON. FULL DISCLOSURE REVIEW SYSTEM
    CENTRALSCOPE 12
    MONITOR, MODEL 2817
    7620 REMOTE CENTRAL STATION REPEATER
    HORIZON DISPLAY CONTROLLER PART # 266-200-010
    SMDS460 SURGICAL MONITOR DISPLAY SYSTEM
    MODEL VY-800RA OPTIONAL ACCESSORY TO BSM 8500A
    Q-CATH RM

    What is a Predicate Device?

    A predicate device is a legally marketed device that a new 510(k) applicant uses to demonstrate substantial equivalence. The FDA's 510(k) pathway requires manufacturers to show that their device has the same intended use and similar technological characteristics as one or more predicate devices already cleared for commercial distribution.

    Finding the right predicate is a critical step in 510(k) strategy. Manufacturers typically search for cleared devices with the same FDA product code, which groups devices by their intended use and regulatory classification. This tool helps you identify potential predicates by browsing all clearances within a product code.

    Note that predicate devices must be legally marketed — they cannot be devices that were cleared but never commercialized, or devices subject to a mandatory recall. The determination of substantial equivalence considers intended use, technological characteristics, and performance data.

    Popular Product Codes

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